Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of accuracy verification documentation for the Biopsy interpretation of patient specimens and interview with the facility personnel on 8/27/26 at 10:30 AM, the laboratory failed to verify the accuracy of Biopsy interpretation of patient specimens performed under the subspecialty of Histopathology at least twice annually during 2025. Findings include: 1. This laboratory performs Biopsy interpretation of patient specimens under the subspecialty of Histopathology with an annual test volume of 16,000 2. Accuracy verification documentation reviewed during the survey indicated the laboratory failed to verify the accuracy of Biopsy interpretations of patient specimens at least twice annually during 2025. 3. The facility personnel interviewed on 8/27/26 at 10:30 AM confirmed the laboratory failed to verify the accuracy of Histopathology testing at least twice annually during 2025. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on established quality assessment (QA) practices and interview with the facility personnel, the laboratory failed to follow their estabilshed QA practices from March Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 2025 through February 2026. Findings include: 1. This facility's established QA practices includes a monthly review and completion of their QA log which includes reviews of all pre-analytical to post-analytical activites. 2. Based on a review of QA records on the survey date of 8/27/26, the facility failed to perform this monthly QA review from March 2025 through February 2026. 3. The facility personnel interviewed on 8/27/26 at 10:30 AM confirmed the laboratory failed to follow established QA practices from March 2025 through February 2026. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on established quality assessment (QA) practices and interview with the facility personnel, the laboratory failed to follow their estabilshed QA practices from March 2025 through February 2026. Findings include: 1. This facility's established QA practices includes a monthly review and completion of their QA log which includes reviews of all pre-analytical to post-analytical activites. 2. Based on a review of QA records on the survey date of 8/27/26, the facility failed to perform this monthly QA review from March 2025 through February 2026. 3. The facility personnel interviewed on 8/27/26 at 10:30 AM confirmed the laboratory failed to follow established QA practices from March 2025 through February 2026. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on established quality assessment (QA) practices and interview with the facility personnel, the laboratory failed to follow their estabilshed QA practices from March 2025 through February 2026. Findings include: 1. This facility's established QA practices includes a monthly review and completion of their QA log which includes reviews of all pre-analytical to post-analytical activites. 2. Based on a review of QA records on the survey date of 8/27/26, the facility failed to perform this monthly QA review from March 2025 through February 2026. 3. The facility personnel interviewed on 8/27/26 at 10:30 AM confirmed the laboratory failed to follow established QA practices from March 2025 through February 2026. -- 2 of 2 --